FDA Licenses First Freeze-Dried Plasma Product

Introducción

The FDA licensed Ezplaz, the first freeze-dried plasma product available to adults in need of transfusion, on Wednesday.

Ezplaz is intended for patients who need plasma — such as those who are bleeding, need massive transfusion, or are bleeding while on warfarin — when conventional frozen plasma is not available.

Origen y características del producto

The product is derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments and is available in Group AB and Group A with low-titer anti-B blood types, selected to reduce the risk of giving it to patients in emergencies before their blood type is determined.

Unlike conventional plasma products, Ezplaz can be stored at room temperature, is stable after exposure to temperature fluctuations, and is rapidly reconstituted. The FDA also noted Ezplaz is packaged in a plastic bag rather than a glass bottle, which reduces breaking risks during handling and transport.

Impacto en situaciones críticas

“Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable,” said Karim Mikhail, BPharm, MS, acting director of the FDA’s Center for Biologics Evaluation and Research. “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”

Seguridad y regulación

The safety profile of Ezplaz is in line with other plasma products used for transfusion, the FDA noted.

Freeze-dried plasma was among the first products identified under legislation enacted in 2017 that authorized collaboration between the Department of Defense and the FDA to expedite the development and review of products for serious or life-threatening conditions affecting U.S. military personnel.

The FDA published guidance for manufacturers developing dried plasma products for transfusion in 2019, and Teleflex submitted the biologics license application for Ezplaz in 2021.

Disclaimer

The information provided is intended for educational purposes and should not replace professional medical advice. Always consult a healthcare provider for medical concerns.

Fuente: https://www.medpagetoday.com/emergencymedicine/emergencymedicine/122403